Cleared Traditional

K931626 - CARAPACE STERILE COTTON BALLS

K931626 is an FDA 510(k) clearance for CARAPACE STERILE COTTON BALLS, manufactured by Carapace, Inc.. The device is a Class 1 General Hospital device with product code FRL cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K931626 · Carapace, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
244d
Days
Class 1
Risk

K931626 is an FDA 510(k) clearance for the CARAPACE STERILE COTTON BALLS. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on December 2, 1993 after a review of 244 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5300 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Carapace, Inc. devices

FDA 510(k) Submission Details - K931626

510(k) Number K931626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date December 02, 1993
Days to Decision 244 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 129d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

FRL Device Classification - Class 1, General Controls

Product Code FRL Fiber, Medical, Absorbent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FRL Fiber, Medical, Absorbent

All 10
Devices cleared under the same product code (FRL) and FDA review panel - the closest regulatory comparables to K931626.
ICAN COTTON RAYON BALLS
K914081 · Icn Pharmaceuticals, Inc. · Oct 1991
TRACH CLEANING TRAY
K811990 · Associated Medical Products Co. · Jul 1981
UTENSIL & PROCEDURE TRAYS
K810242 · American Hospital Supply Corp. · Apr 1981
SURGITEK FOERSTER FACE LIFT BANDAGE
K800248 · Medical Engineering Corp. · Feb 1980
SURGITEK FOERSTER MAMMARY BANDAGE
K800249 · Medical Engineering Corp. · Feb 1980
SORBIES
K792295 · American Hospital Supply Corp. · Dec 1979